MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM BEADED 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Local Reaction (2035); Scar Tissue (2060); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); No Code Available (3191)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 00801803203 femoral head sterile product 12/14 taper lot#: 61693390, catalog#: 00630505032 liner standard 32 mm lot#: ni.Radiographs were provided, however, the event could not be confirmed.Review of the available records identified the following : the right hip components were anatomically aligned.Osteopenia was observed along the proximal femur.No other abnormalities were noted.A definitive root cause cannot be determined.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00693.

Event Description

It was reported that a patient underwent a revision procedure approximately 8 years post implantation due to pain and elevated metal ion levels.The 12 mm epoch stem was solid.No further event information available at the time of this report.

Event Description

It was reported that a patient underwent an initial right hip arthroplasty and was revised eight and a half years later due to pain and altr.The liner and heads were removed, the liner was damaged upon removal.A new liner and biolox head were re-implanted.The 12 mm epoch stem was solid.No additional information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: a1, b1, b4, b5, b7.E1, g3, g4, h2, h6 if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).D11: 00620005022 shell porous (b)(6); 00630505032 liner standard (b)(6); 00801803203 femoral head (b)(6).An additional mdr report was filed for this event, please see associated report: 0002648920-2021-00026.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records identified the following: the patient underwent a revision procedure due to failed hip arthroplasty.During the revision procedure, altr was found in the wound.Extensive debridement was performed.Clear fluid, and dark stained synovium were observed in the capsule.There was corrosion at the head-trunnion junction.Minimal osteolysis was present around the shell, but the shell was well fixed.The head and liner were replaced with new zimmer biomet products.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient underwent an initial right hip arthroplasty and was revised right and a half years later due to pain and altr.During the surgery, it was found that there was corrosion at the head-trunnion junction and minimal osteolysis was present around the shell.The liner and heads were removed, the liner was damaged upon removal.A new liner and biolox head were re-implanted.The 12 mm epoch stem was solid and the shell was solid.No additional information is available.

• Brand Name: FEMORAL STEM BEADED 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9555264
• MDR Text Key: 173886838
• Report Number: 0001822565-2020-00068
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00408801206
• Device Lot Number: 61498367
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 58